Responsible for the overall supervision, direction, and coordination of the activities of lab technicians through scientist levels in the Grand Island Microbiology Laboratory. This individual reports to the area supervisor and is responsible for coordinating the timely execution of routine and special finished product testing and environmental monitoring. Anticipates the materials needed for future scheduled projects. Keeps Microbiology Supervisor informed of all departmental activities. This position directly supervises up to 8 direct reports as needed.Responsibilities
- Supervises daily operational activities.
- Participates in the hiring of new departmental personnel and conducts performance evaluations.
- Develops and validates new microbiological test methods.
- Reviews work performed by department staff for accuracy, completeness and conformance to specifications.
- Schedules personnel for complete coverage of environmental monitoring/testing.
- Generates new Standard Operating Procedures for microbiology test procedures.
- Monitors and tracks test performance to ensure all testing/monitoring requirements are met each shift and each week.Re-assigns tasks as needed.
- Ensures adequate resources are available to perform monitoring and testing as required to meet laboratory, quality and production needs.
- Mentors and develops new department personnel including training in standard operating procedures and training modules.
- Keep's team members informed of all relevant events impacting the operations and performance of the department.
- Investigates, writes and resolves nonconforming test results by completing thorough Environmental Excursion, Out-of-Specification or Deviation investigations.
- Maintains knowledge of cGMP's and GLP's.
REQUIREMENTSB.S. in Biological Science with 1-3 years progressive pharmaceutical lab experience, 3-5 years preferred. Equivalent combined of education and experience in pharmaceutical manufacturing, related industrial or clinical experience accepted. Excellent verbal and written communication skills are essential.Are responsible for
- Maintains knowledge of current compendial methods.
- Provides validation test support.
- Performs environmental monitoring and routine testing of in-process and finished products as needed.
- Works closely with Department Management to create a positive, team oriented atmosphere.
- Performs other duties as assigned by management.
BACHELOR'S DEGREE REQUIREDAdditional Information
- Establishing and maintaining environmental policies making their employees aware of the policy
- Endorsing environmental excellence in their organization
- Establishing controls for the identified significant environmental aspects for his/her function team / department according to procedure and policies
- Ensuring that the EMS is properly implemented and that environmental matters are properly handled at all stages
- Ensuring that the contractors work activities are performed in compliance with the environmental regulations
- Ensure that EMS goals and targets are recognized and achieved
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.